The ethics of clinical trials

The ethics of clinical tests is controversial. Paradoxically, instead of moving towards more and more protected conditions, some research still has gray areas because enrolled patients do not always have the same guarantees. For some time now we have been asking for more rigorous and internationally shared rules when it comes to research studies management, particularly those conducted abroad and involving vulnerable people in need of special protection (such as children, poor people, citizens of countries with a Low Human Development Index). Perhaps the recent, dramatic news in the international press will be used to encourage an effective mobilization.

It has been estimated that in 2010, in India, 668 people died who were involved in clinical tests. India has very bland rules when it comes to the patient's informed consent and it does not foresee any type of compensation for those who are struck with illnesses following clinical experiments. The Central Drugs Standard Control Organization (CDSCO), which is similar to Italy's Agency for Medicine, are the authorities that have begun pressing for a reform of the system with mechanisms for greater control on ethics committees, researchers' activities and sponsors. A proposal was put forth in order to calculate the entity of compensation on the basis of wealth, age and type of disability caused by the clinical tests. This prospect has alarmed some companies and scholars who fear that the rise of inspections and costs associated with the proposed reform can turn into heavy limitations for the advancement of research. The debate is very heated, also in view of the fact that the Parliamentary Committee on Health, Welfare and Family, has accused the CDSCO of placing the industry's interests before those of helpless patients.

Elsewhere too, for that matter, there are still doubts and ethical questions with no easy solution. One of the thorniest questions regards the possibilities developed by the study of the human genome. For example characteristics can emerge from a DNA sequence taken for studying a specific issue such as cancer which may then lead to a totally different area of study such as the HIV virus gene. What should one do with this information if the patient has given his cells on the condition that he/she remain anonymous? Informed consent signed by the persons who donate tissue for this type of study is designed so that the person cannot be contacted. The rationale for this behavior is linked to a different objective. It does not provide assistance or cures for any problems encountered by chance on the samples being studied: in fact the goal, at least at this stage of the studies, is only to increase knowledge. In other words, the researcher is not the physician of patients who donate tissues and cannot and should not act as such. In short, it may be necessary to break the rules and inform the patient of an important risk that has emerged by chance. The danger too could be transmitted to their family; people that are difficult to trace and often no longer related to the person who donated the sample. What should be done in these cases? What is the researcher's duty? Where does the researcher's responsibility end and, more prosaically, who will guarantee the time and resources needed to contact all those potentially affected?

It 'obvious that this is a difficult problem and it is stimulating the development of new policy by the United States federal government. It is in this country that 50% of all studies currently in progress take place (46.8 tests per million people, compared to 11.5 in Europe and 3.3 in Russia, according to data released by the National Institute of Health). But things are changing.

In Russia, the number of people who are undergoing clinical tests, particularly targeted to testing new drugs, is in constant increase and this is linked to the possibility of obtaining access to free medical treatment. For this reason more and more experimental studies supported by U.S. and European pharmaceutical companies are conducted in Russia: here the costs are lower and the testing time, leaner bureaucracy and volunteers are in abundance. The Putin government, eager to open the country to new types of investments, in 2010 passed a law requiring pharmaceutical companies that want to launch a product on the Russian market to test it locally. This law gave an immediate boost to the number of tests approved locally: 448 in the first six months of 2012, compared to 201 in the first six of the previous year. An 96% increase! Similar measures have been adopted by Singapore, South Korea and China. The direct consequence these governments hope for is to obtain new resources for their facilities, free training for local professionals and quality care for patients.

From an ethical point of view the question is what is the purpose of a test: the search for new therapeutic options or direct treatment? In addition, pharmaceutical companies who test their new products abroad use the results of the tests to obtain the marketing authorization for their country of origin. In some cases, the conditions under which the study was conducted have raised concerns. On other occasions the national results differ from those of the tests conducted abroad. It is imperative that the rigorousness of checks and the compliance with rules should be expected and guaranteed everywhere, with a view to a truly global advancement of knowledge and a sharing of opportunities for health care.